Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.A Belgian Precision 2 study

This research study, called a Phase II trial, is investigating a medicine called Lynparza (known scientifically as Olaparib). It's for people with advanced cancers that have spread or can't be cured by other treatments. The study is particularly interested in patients whose cancers have specific genetic changes (mutations) in genes that are important for DNA repair. This type of cancer is often called a 'basket tumour' because it includes different cancers with this shared genetic feature. The main goal is to find out how many people respond to Lynparza, meaning their tumours shrink or stop growing, and for how long. Researchers also want to understand if certain genetic markers in the tumours are linked to how well the treatment works. They will also look at the overall safety of the treatment and how long people live while on the study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Belgian Society Of Medical Oncology

Enrolment target

351

Start

18 Oct 2024

Basket tumors

What is this study about?

This study is a clinical trial, which is a carefully planned medical research study involving volunteers. It's called a 'Phase II' study, which means researchers are primarily trying to see if a new medicine works and if it's safe enough to continue studying in more people. Clinical trials are how new treatments become available to patients.

The medicine being tested here is called Lynparza (or olaparib). It's a type of targeted therapy that works by blocking a specific protein involved in repairing damaged DNA in cancer cells. The idea is that if cancer cells already have problems repairing DNA due to certain genetic changes, blocking this pathway even further makes it harder for them to survive, while healthy cells are less affected.

Researchers are particularly interested in people whose cancers have specific genetic changes, called 'mutations,' in genes that help repair DNA. These mutations can either be inherited (germline) or develop within the tumour itself (somatic). The study aims to understand if Lynparza is an effective treatment for these types of advanced cancers.

Key takeaways

Tests Lynparza (Olaparib) for advanced cancers.
Specifically targets cancers with certain DNA repair gene changes.
Aims to see if tumours shrink and for how long.
Open to adults 18 and over, any gender.
Involves taking tablets and regular clinic visits.
Safety and side effects will be carefully monitored.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

One of the most important things is that you must have an advanced cancer. This means your cancer has either spread to other parts of your body, or it's not responding to other standard treatments and can't be cured with surgery or radiation alone.

Crucially, your cancer must also have specific genetic changes (mutations) in certain genes. These genes are involved in how your body repairs damaged DNA. Your doctor would likely have already done tests to check for these genetic changes in your tumour or in your blood. If your cancer doesn't have these specific mutations, you wouldn't be able to join this particular study.

Quick self-check

Are you 18 years old or older?
Do you have advanced cancer (meaning it has spread or isn't responding to other treatments)?
Have your doctors found specific genetic changes (mutations) in your cancer's DNA repair genes?
Are you able to take medication by mouth?
Are you willing and able to attend regular hospital visits for check-ups and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be given Lynparza tablets. This medicine comes in two strengths: 100 mg and 150 mg. You would likely take the tablets at home, but follow a strict schedule. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to see how your cancer is responding to the treatment. These scans, often called RECIST 1.1, help doctors measure the size of your tumours.

During these visits, doctors and nurses would also carefully monitor you for any side effects from the medication. You'd be asked about how you're feeling and any new symptoms you might have. The study would continue for as long as the treatment is helping you and you're not experiencing severe side effects, or until your doctor decides it's no longer the best option for you. After stopping the treatment, you would likely have follow-up appointments to track your health over time.

Potential risks and benefits

Participating in this study might offer a potential benefit: Lynparza could help to shrink your tumour or stop it from growing, and it might work when other treatments haven't. However, as with any medication, there are potential risks, including side effects like tiredness, nausea, or more serious problems, which will be carefully monitored. You will be told about all known risks before you decide to join. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Belgium

Common questions

What kind of cancer is this study for?

This study is for people with advanced cancers that have specific genetic changes (mutations) in genes that are important for DNA repair. These can be many different types of advanced cancer, as long as they have these particular genetic features.

What is Lynparza?

Lynparza is a targeted therapy medicine. It works by blocking a process that cancer cells use to repair their DNA. It aims to kill cancer cells that already have problems repairing DNA due to genetic changes.

What does 'Phase II' mean?

A 'Phase II' study like this one means that researchers are trying to find out if the new medicine works well enough to treat cancer, and they are also looking closely at its safety and any side effects.

Will I get the actual drug or a placebo (dummy drug)?

In this specific study, everyone who participates and meets the criteria will receive Lynparza. There is no placebo arm in this trial.

What if the treatment isn't helping me?

The doctors and nurses will regularly check how you're responding to the treatment through scans and tests. If the treatment isn't working or if you experience severe side effects, your study doctor will discuss other treatment options with you, and you can stop participating in the study.